Drugs
The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug “skinny labels” threatens to undermine the Hatch-Waxman framework for bringing generics to market by exposing compliant generic manufacturers to inducement claims based on ordinary, non-infringing behavior. A DoJ amicus brief argues
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Rare disease drug developers and patient advocates are applauding a series of new guidance documents from the U.S. Food and Drug Administration, telling Clinical Trials Arena that the policies bring long-awaited clarity to regulatory expectations and could help reduce risk in a high-stakes development landscape. Over the
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The U.S. Senate Special Committee on Aging is raising concerns about FDA’s handling of foreign drug manufacturing violations and how those decisions could affect military readiness and national security. In a 2/18 letter to Defense secretary Pete Hegseth, chairman Rick Scott (R-FL) and ranking member Kirsten
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FDA has accepted for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia (sHTG). It's currently approved as Tryngolza for familial chylomicronemia syndrome in the U.S. The agency set a user fee review action target date of 6/30. Ionis said the submission’
Drugs
Eli Lilly says its investigational oral GLP-1 receptor agonist orforglipron delivered significantly greater reductions in blood sugar and body weight than oral semaglutide (Novo Nordisk’s Rybelsus) in a 52-week head-to-head Phase 3 trial of adults with Type 2 diabetes. Results from the ACHIEVE-3 study,
Drugs
FDA has granted Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations, as detected by an FDA-authorized test. Zongertinib is a kinase inhibitor evaluated under the FDA
Drugs
FDA is preparing to roll out a new bonus program that will reward drug and biologic reviewers for completing high-quality drug reviews ahead of schedule, in a bid to accelerate regulatory decisions, according to a Bloomberg news report. According to an FDA official, the incentive program will provide quarterly
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A leading rare disease advocacy group on Thursday urged lawmakers to increase oversight of the Food and Drug Administration, warning that inconsistent use of regulatory flexibility and a drop in advisory committee meetings are creating uncertainty that could delay life-saving therapies. Testifying before the U.S. Senate Special Committee
Drugs
FDA has approved a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and children ages 6 and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery, marking the first therapy specifically for the condition. Allergic fungal rhinosinusitis is
Drugs
CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advances, collaborative scientific efforts, and regulatory science initiatives aimed at improving public health and regulatory decision-making. According to the report, DARS completed numerous applied research projects this year, advancing scientific understanding in several
Drugs
Marking Rare Disease Week, Rep. Josh Gottheimer (D-NJ) has introduced five bipartisan bills to help find cures. A media release says the bills are: * Gwenn’s Law (in honor of Gottheimer’s mother, who died due to sarcoidosis) to increase the number of women in clinical trials for rare
Drugs
CDER has published a list of 81 new and revised guidances it plans to issue in this calendar year. The largest number of guidances in one category is 24 on aspects of generic drugs. The guidance categories and number of guidances in each category are: * administrative/procedural (8) * biosimilars (5)
Drugs
A 7/30-8/12/2025 FDA inspection at the AQ USA drug manufacturing facility in Lynden, WA, doing business as Ross Healthcare, identified five significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/12 Warning Letter notes that the company operates a drug manufacturing
Drugs
FDA has granted Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combination regimens to treat certain patients with metastatic colorectal cancer (CRC). Encorafenib previously received accelerated approval in 2024 in combination with cetuximab and mFOLFOX6 for previously untreated metastatic CRC with a BRAF
Drugs
Novo Nordisk says its investigational triple agonist UBT251 demonstrated up to 19.7% mean weight loss after 24 weeks in a Phase 2 trial in China, adding a new entrant to the intensifying race for next-generation obesity drugs. UBT251, a once-weekly injectable peptide targeting the receptors for GLP-
Drugs
FDA has granted Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically designed to lower plasma arginine in patients with Arginase 1 Deficiency, a rare and progressive metabolic disorder. The action allows Loargys to be used to treat hyperargininemia in adults and children
Drugs
FDA has issued Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related violations tied to the company’s iLet Bionic Pancreas System. The 1/28 letter follows a 6/25 inspection of the company’s Irvine, CA facility, concluding that the company’s
Drugs
FDA has issued a Warning Letter to London-based drug manufacturer A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising concerns about microbiological testing and data integrity at the company’s facility. The 2/12 letter said an unannounced inspection conducted 9/2025 at the
Drugs
FDA has issued a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause. It is intended for sponsors seeking approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized
Drugs
FDA has approved AstraZeneca’s Calquence (acalabrutinib) for use in combination with AbbVie and Genentech’s Venclexta (venetoclax), a chemotherapy-free regimen for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), clearing their use as an initial treatment option. The approval is based on results from the
Drugs
Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but failed to meet its primary objective of proving it was not inferior to Eli Lilly’s rival therapy tirzepatide (Zepbound and Mounjaro). In the 84-week Phase 3 REDEFINE
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FDA has appointed a veteran artificial intelligence executive to lead its digital health policy unit, signaling a sharper regulatory focus on AI-driven medical technologies. Rick Abramson, who previously served as chief medical officer at a subsidiary of Harrison.ai, an Australian firm known for developing advanced AI systems designed